High-cost, specialty medicines account for an ever-increasing proportion of new treatments coming to market, this according to this year’s annual report from the Patented Medicine Prices Review Board (PMPRB).
The Meds Entry Watch, 2018, published this week by the PMPBR, under the National Prescription Drug Utilization Information System initiative, is a report which focuses on medicines that received first-time market approval from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) or Health Canada in 2017 and 2018. The report also analyses their uptake, pricing, sales and availability as of the last quarter of 2018.
“Meds Entry Watch is an annual PMPRB publication that explores the dynamics of new medicines entering Canadian and international markets, providing information on their availability, sales and prices,” say the report’s authors. The report provides a retrospective analysis of medicines that have entered the market since 2009, offers an analysis of the new medicines approved in 2017, and provides a preliminary examination of those approved in 2018.
According to the report, there is a continued trend toward high-cost medicines, with lower-cost medicines accounting for a smaller share of new approvals in recent years. More new medicines were approved in 2017 relative to previous years, with a “significant increase” in the number of high-cost orphan and oncology medicines entering the market. (An orphan drug is one developed to treat medical conditions that are so rare, it would not be profitable to produce the drug without government assistance.)
The report says 52 new medicines received market approval through the FDA, EMA or Health Canada in 2017. Of those, 46 per cent received an orphan designation from the FDA or the EMA. Thirty-eight per cent of the new medicines were biologic therapies. 14 of the new medicines were oncology medicines with costs exceeding $5,000 per 28-day treatment. Twenty of the new medicines were non-oncology medicines with annual costs exceeding $10,000. Only 27 of the 52 new medicines approved in 2017 had market authorization in Canada by the end or 2018 and only 18 of those 27 approved drugs recorded sales in Canada by the end of 2018.
In 2018, 51 new medicines received market approval from the FDA, the EMA or Health Canada. Nearly 60 per cent of those new medicines received an orphan designation. More than one quarter of new medicines were biologic therapies. Only 19 of the 52 new medicines had approval in Canada by the third quarter of 2019. New and extended indications for previously marketed medicines meanwhile, contributed $594-million to the $1.07 billion growth in pharmaceutical sales in Canada between 2017 and 2018.
